Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia

Inclusion Criteria:

• Definitive diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria

  • Must have high-risk B-CLL as defined by ≥ one of the following:

    • High-risk cytogenetics (either 17p deletion and/or 11q deletion)
    • Unmutated immunoglobulin heavy chain gene rearrangement
  • Zap-70 and CD38 expression on leukemic cells will not be used as eligibility criteria for enrollment into the clinical trial
• No prior treatment for the management of B-CLL
• Patients must have B-CLL requiring therapy as defined by the IWCLL criteria

• Must have measurable disease meeting one of the following criteria:

  • Absolute lymphocyte count > 5,000/μL
  • Measurable lymphadenopathy or organomegaly

• No tumor lysis syndrome (TLS) by Cairo-Bishop definition

  • Patients with correction of electrolyte abnormalities allowed
• ECOG performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 75,000/mm³
• Creatinine clearance ≥ 30 mL/min
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 3 times ULN (≤ 5 times ULN if hepatic metastases are present)

• Uric acid normal

  • Patients with elevated uric acid allowed provided it is corrected with appropriate pharmacologic measures
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must commit to continued abstinence from heterosexual intercourse or use 2 acceptable methods of contraception (1 highly effective method and 1 additional effective method) ≥ 28 days prior to, during, and for ≥ 28 days after discontinuing lenalidomide
• Able to adhere to the study visit schedule and other protocol requirements
• No serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
• No condition, including the presence of laboratory abnormalities, that would place the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
• No known hypersensitivity to thalidomide or lenalidomide
• No history of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs
• No history of any other cancer except non-melanoma skin cancer or carcinoma in-situ of the cervix or cancer for which the patient is in complete remission and off therapy for > 3 years
• No cardiac arrest within the past 6 months
• No known history of hepatitis B infection, positive hepatitis B surface antigen, or positive hepatitis C antibody
• No other concurrent anti-cancer agents or treatments
• More than 28 days since any prior experimental drug or therapy
• Aspirin (81 or 325 mg) or warfarin sodium daily as prophylactic anticoagulation required
• No prior lenalidomide